Coated medical devices

• US 8,303,609 B2
• Filed: 09/28/2001
• Issued: 11/06/2012
• Est. Priority Date: 09/29/2000
• Status: Active Grant

• Current Assignee: Wyeth (Pfizer Inc.)
• Original Assignee: Cordis Corporation (Cardinal Health, Inc.), Wyeth (Pfizer Inc.)
• Inventors: Lentz, David Christian, Llanos, Gerard H., Roller, Mark B., Scopelianos, Angelo, Weadock, Kevin
• Primary Examiner(s): McDermott, Corrine M
• Assistant Examiner(s): RYCKMAN, MELISSA K
• Application Number:
  US09/966,447
• Publication Number:
  US 20020133183A1
• Time in Patent Office: 4,057 Days
• Field of Search: 606/153, 606/219, 623/1.36
• US Class Current: 606/153
• CPC Class Codes: A61B 17/00491 Surgical glue applicators surgical adhesives A61L24/00; two-component delivery syringes A61M5/19
• CPC Class Codes: A61B 17/0469 Suturing instruments for use in minimally invasive surgery, e.g. endoscopic surgery
• CPC Class Codes: A61B 17/0644 penetrating the tissue, deformable to closed position
• CPC Class Codes: A61B 17/11 for performing anastomosis; Buttons for anastomosis
• CPC Class Codes: A61B 17/115 Staplers for performing anastomosis in a single operation
• CPC Class Codes: A61B 2017/06028 by means of a cylindrical longitudinal blind bore machined at the suture-receiving end of the needle, e.g. opposite to needle tip
• CPC Class Codes: A61B 2017/0641 having at least three legs as part of one single body
• CPC Class Codes: A61F 2/064 with special features to facilitate anastomotic coupling anastomosis of natural blood vessels A61B17/11
• CPC Class Codes: A61F 2/91 made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
• CPC Class Codes: A61F 2/915 with bands having a meander structure, adjacent bands being connected to each other
• CPC Class Codes: A61F 2002/91533 characterised by the phase between adjacent bands
• CPC Class Codes: A61F 2002/91558 connected peak to peak
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2250/0067 Means for introducing or releasing pharmaceutical products into the body
• CPC Class Codes: A61F 2310/0097 Coating or prosthesis-covering structure made of pharmaceutical products, e.g. antibiotics
• CPC Class Codes: A61F 2310/00976 Coating or prosthesis-covering structure made of proteins or of polypeptides, e.g. of bone morphogenic proteins BMP or of transforming growth factors TGF
• CPC Class Codes: A61L 17/145 Coating
• CPC Class Codes: A61L 2300/608 having two or more layers
• CPC Class Codes: A61L 27/34 Macromolecular materials
• CPC Class Codes: A61L 29/085 Macromolecular materials
• CPC Class Codes: A61L 31/10 : Macromolecular materials
• CPC Class Codes: A61L 31/16 : Biologically active materials, e.g. therapeutic substances A61L31/047 takes precedence
• CPC Class Codes: C08L 27/12 : containing fluorine atoms
• CPC Class Codes: C08L 27/14 : Homopolymers or copolymers of vinyl fluoride
• CPC Class Codes: C08L 27/16 : Homopolymers or copolymers or vinylidene fluoride

Abstract

Medical devices, and in particular implantable medical devices, may be coated to minimize or substantially eliminate a biological organism'"'"'s reaction to the introduction of the medical device to the organism. The medical devices may be coated with any number of biocompatible materials. Therapeutic drugs, agents or compounds may be mixed with the biocompatible materials and affixed to at least a portion of the medical device. These therapeutic drugs, agents or compounds may also further reduce a biological organism'"'"'s reaction to the introduction of the medical device to the organism. Various materials and coating methodologies may be utilized to maintain the drugs, agents or compounds on the medical device until delivered and positioned.

Claims

1. A device for joining substantially tubular organs in a living organism, comprising:

an anastomosis device for connecting a graft vessel to a target vessel such that the two vessels are in fluid communication, the anastomosis device including a fastening flange and a plurality of staples connected to the fastening flange and having sharpened ends with barbs, the fastening flange comprising a single wire ring structure having a substantially sinusoidally shaped initial configuration for reduced profile delivery and a substantially flat profile final configuration post deployment, and the plurality of staples being configured to spring from a restraint position to a position substantially perpendicular to the ring structure and finally to an everted loop position through the graft vessel and target vessel, the plurality of staples extending from the wire ring structure in the same direction as the substantially sinusoidally shaped configuration and extending substantially beyond the wire ring for eversion;

a primer layer affixed to at least a portion of the anastomosis device;

a biocompatible vehicle affixed to the primer layer covering the at least a portion of the anastomosis device as a thin polymeric coating covering the elements of the device, wherein the biocompatible vehicle comprises a polyfluoro copolymer comprising polymerized residue of a first moiety comprising vinylidenefluoride, and polymerized residue of a second moiety comprising hexafluoropropylene and which is copolymerized with the first moiety, thereby producing the polyfluoro copolymer, wherein said polyfluoro copolymer comprises from about 55 to about 65 weight percent of the polymerized residue of the vinylidenefluoride copolymerized with from about 45 to about 35 weight percent of the polymerized residue of hexafluoropropylene, the primer layer and the polymer are similar in chemical composition with the primer layer being a diluted version of the polyfluoro copolymer, and wherein the weight of the biocompatible layer being about 0.4 to about 10 percent by weight;

a rapamycin in therapeutic dosages incorporated into the biocompatible vehicle for the treatment of reactions by the living organism caused by the anastomosis device or the implantation thereof, the thin polymeric coating being configured to control the elution rate of the rapamycin into the surrounding tissue; and

at least one top coating for delaying the release of the rapamycin.